登记号
CTR20192333
相关登记号
曾用名
药物类型
化学药物
临床申请受理号
JXHL1900011
适应症
甲型流感
试验通俗题目
Pimodivir在有并发症风险甲流非住院患者的疗效和安全性研究。
试验专业题目
评价Pimodivir联合标准疗法治疗有并发症风险的甲流非住院患者的疗效和安全性的III期、随机、双盲、安慰剂对照研究。
试验方案编号
63623872FLZ3002 修正案1
方案最近版本号
修正案1
版本日期
2018-02-09
方案是否为联合用药
企业选择不公示
申请人信息
申请人名称
联系人姓名
刘伊雯
联系人座机
021-33377535
联系人手机号
15921850139
联系人Email
yliu120@its.jnj.com
联系人邮政地址
上海市-上海市-邮政地址：上海市徐汇区桂箐路65号 新研大厦A楼6层
联系人邮编
200233
临床试验信息
试验分类
安全性和有效性
试验分期
III期
试验目的
本研究的目的是评价Pimodivir联合标准疗法（SOC）治疗与安慰剂联合SOC治疗，在甲型流感病毒感染且具有并发症风险的青少年、成人和老年非住院受试者中的临床和病毒学获益。
随机化
随机化
盲法
双盲
试验范围
国际多中心试验
设计类型
平行分组
年龄
13岁(最小年龄)至
85岁(最大年龄)
性别
男+女
健康受试者
无
入选标准
- 至门诊就医，症状提示诊断急性流感，至少出现一种呼吸系统症状并至少出现一种全身症状，如果在流感发作前没有出现上述症状，那么它们的评分至少是“中度”，如果在流感发作前已经出现上述症状（根据ePRO设备上Flu-iiQTM模块1和之前存在症状问卷的受试者评定），评分就要比之前更差。症状必须包括下列分类： 1. 呼吸系统症状：咳嗽、咽喉痛、鼻塞；2. 全身症状：头痛、身体酸痛、感觉发热、疲乏
- 症状发作后采用快速流感诊断试验（RIDT）或者基于PCR的方法（如果有）或其他快速分子诊断方法，检测甲型流感病毒感染阳性。
- 筛选时不需要住院治疗。只要医生认为不需要住院，那么预期在急诊室或医院留观＜24小时不算住院。
- 要在流感症状发作后≤72小时入组并启动研究药物治疗。
- 13-65岁（含）的受试者必须至少患有下列一种疾病：心血管或脑血管疾病（包括充血性心脏病、慢性心力衰竭、冠状动脉疾病或脑卒中；不包括孤立的高血压）；慢性肺病（例如哮喘、慢性阻塞性肺疾病［COPD］或囊性纤维化）；因为疾病或药物导致免疫系统功能障碍（例如人类免疫缺陷病毒［HIV］感染受试者、癌症或慢性肝病或肾病受试者［肾损害＞3个月，定义为肾脏的结构和功能异常，有或无GFR下降，表现为病理学异常；或肾脏损害标记物，包括血液或尿液成分出现异常，或影像学检查出现异常］，或受试者长期使用全身性类固醇治疗。
排除标准
- 在首剂研究药物前2周内，接受过1剂以上流感抗病毒药物（例如OST或扎那米韦），或者任何剂量的利巴韦林，或者在筛选前1天接受静脉内（IV）peramivir治疗。
- 筛选前30天（含）发作过不稳定型心绞痛或心肌梗死
- 出现具有临床意义的心律失常、不能控制的不稳定型房性心律失常、或持续的室性心律失常，或者具有尖端扭转型室性心动过速综合征的危险因素。
- 已知存在重度肝损害（Child Pugh C级肝硬化）或患有慢性丙型肝炎病毒感染、正在接受丙型肝炎抗病毒治疗。
- 研究者认为存在重度免疫功能缺陷（例如已知白细胞分化群4+［CD4+］计数＜200个细胞/mm3，中性粒细胞绝对计数＜750/mm3，筛选前2周内完成首个化疗疗程，筛选前1年内干细胞移植病史，肺移植病史）
- 已知对pimodivir或其辅料过敏、发生过超敏反应或者不能耐受
试验分组
试验药
| 名称 | 用法 |
|---|---|
|
中文通用名:Pimodivir
|
用法用量:薄膜衣片300mg/片，口服，每次600 mg，每日两次，连续服用五日
|
对照药
| 名称 | 用法 |
|---|---|
|
中文通用名:安慰剂
|
用法用量:薄膜衣片，口服，每次两片，每日两次，连续服用五日
|
|
中文通用名:达菲（奥司他韦）
|
用法用量:胶囊75mg/粒
口服，每次1粒，每日两次，连续服用五日
|
终点指标
主要终点指标
| 指标 | 评价时间 | 终点指标选择 |
|---|---|---|
| 主要终点是“至流感相关症状消退的时间”，由患者报告结局（PRO）测量Flu-iiQTM进行评估。 | 基线至第28天 | 有效性指标 |
次要终点指标
| 指标 | 评价时间 | 终点指标选择 |
|---|---|---|
| 发生不良事件受试者人数评估安全性耐受性 | 至第28天 | 安全性指标 |
| 发生实验室异常受试者人数评估安全性耐受性 | 至第28天 | 安全性指标 |
| 发生心电图异常受试者人数评估安全性耐受性 | 至第28天 | 安全性指标 |
| 发生生命体征异常受试者人数评估安全性耐受性 | 至第28天 | 安全性指标 |
| 住院受试者比例 | 至第28天 | 有效性指标+安全性指标 |
| 在治疗开始后发生流感并发症的受试者比例 | 至第28天 | 有效性指标 |
| 恢复到日常活动的时间 | 至第28天 | 有效性指标 |
| 至发热消除的时间 | 至第14天 | 有效性指标 |
| 全因死亡受试者人数 | 至第28天 | 有效性指标+安全性指标 |
| Pimodivir血浆最大浓度 | 第3天，第6天（第5天晚上最后一剂Pimodivir用药后12小时） | 有效性指标 |
| Pimodivir血浆谷浓度 | 第6天（第5天晚上最后一剂Pimodivir用药后12小时） | 有效性指标 |
| 达到Pimodivir血浆最大浓度的时间 | 第3天，第6天（第5天晚上最后一剂Pimodivir用药后12小时） | 有效性指标 |
| 血浆浓度-时间曲线下面积 给药后0至12小时AUC（0-12） | 第3天，第6天（第5天晚上最后一剂Pimodivir用药后12小时） | 有效性指标 |
| 口感问卷测定的Pimodivir在青少年受试者中的可接受性 | 第1天和第5天（晚上），或第6天（早上） | 有效性指标 |
| 吞咽问卷测定的Pimodivir在青少年受试者中的可接受性 | 第1天和第5天（晚上），或第6天（早上） | 有效性指标 |
| 出现对Pimodivir耐药的受试者人数 | 至第14天 | 有效性指标 |
| 至流感病毒转阴时间 | 至第14天 | 有效性指标 |
| 病毒载量随时间变化 | 至第14天 | 有效性指标 |
| 10项个体流感相关症状中每一项的至消退时间，由PRO测量Flu-iiQTM问卷进行评估。 | 至第28天 | 有效性指标 |
数据安全监察委员会（DMC）
有
为受试者购买试验伤害保险
有
研究者信息
| 姓名 | 学位 | 职称 | 电话 | 邮政地址 | 邮编 | 单位名称 | |
|---|---|---|---|---|---|---|---|
| 王辰 | 医学博士 | 中国工程院院士，主任医师，教授，博士生导师 | 010-64222969 | Tks0423@hotmail.com | 北京市-北京市-北京市朝阳区樱花东街2号 | 100029 | 中日友好医院 |
各参加机构信息
| 机构名称 | （主要）研究者 | 国家 | 地区 | 城市 |
|---|---|---|---|---|
| 中日友好医院 | 王辰 | 中国 | 北京市 | 北京市 |
| 首都儿科研究所附属儿童医院 | 朱春梅 | 中国 | 北京市 | 北京市 |
| 北京医院 | 李燕明 | 中国 | 北京市 | 北京市 |
| 广东省人民医院 | 高兴林 | 中国 | 广东省 | 广州市 |
| 联勤保障部队第九〇〇医院 | 赖国祥 | 中国 | 福建省 | 福州市 |
| 上海市儿童医院 | 陆敏 | 中国 | 上海市 | 上海市 |
| 四川大学华西医院 | 梁宗安 | 中国 | 四川省 | 成都市 |
| 北京大学第三医院 | 李晓光 | 中国 | 北京市 | 北京市 |
| 中国人民解放军总医院(301医院) | 解立新 | 中国 | 北京市 | 北京市 |
| 浙江大学医学院附属第一医院 | 周建英 | 中国 | 浙江省 | 杭州市 |
| 中山大学孙逸仙纪念医院 | 江山平 | 中国 | 广东省 | 广州市 |
| 复旦大学附属中山医院 | 宋元林 | 中国 | 上海市 | 上海市 |
| 青岛市市立医院 | 唐华平 | 中国 | 山东省 | 青岛市 |
| 河南省人民医院 | 张晓菊 | 中国 | 河南省 | 郑州市 |
| 南昌大学第一附属医院 | 张伟 | 中国 | 江西省 | 南昌市 |
| 哈尔滨医科大学附属第二医院 | 陈宏 | 中国 | 黑龙江省 | 哈尔滨市 |
| 上海市同仁医院 | 张琴 | 中国 | 上海市 | 上海市 |
| 无锡市人民医院 | 赵寅滢 | 中国 | 江苏省 | 无锡市 |
| 贵州省人民医院 | 张湘燕 | 中国 | 贵州省 | 贵阳市 |
| 首都医科大学附属北京地坛医院 | 徐艳利 | 中国 | 北京市 | 北京市 |
| 南方医科大学南方医院 | 孟莹 | 中国 | 广东省 | 广州市 |
| 上海市公共卫生临床中心 | 卢洪洲 | 中国 | 上海市 | 上海市 |
| 复旦大学附属华山医院 | 张文宏 | 中国 | 上海市 | 上海市 |
| Hospital San Roque | Ambasch, German | Argentina | Cordoba | Cordoba |
| Hospital Nuestra Senora de la Misericordia | Minguez, Angel | Argentina | Cordoba | Cordoba |
| Instituto Medico Platense | Alzogaray, Maria Fernanda | Argentina | Buenos Aires | La Plata |
| Hospital Italiano de La Plata | Ramirez Borga, Santiago | Argentina | Buenos Aires | La Plata |
| Hospital Privado Centro Medico de Cordoba S.A | Zarate, Abel | Argentina | Cordoba | Cordoba |
| Sanatorio Allende | Bergallo, Carlos Enrique | Argentina | Cordoba | Cordoba |
| Sanatorio Britanico S.A. | Nannini, Esteban | Argentina | Santa Fe | Rosario |
| Hospital Cordoba | Riera, Fernando Oscar | Argentina | Cordoba | Cordoba |
| Sanatorio Juan XXIII | Ariza, Horacio Alberto | Argentina | Rio Negro | General Roca |
| CEMIC | Bonvehi, Pablo Eduardo | Argentina | Ciudad Autonoma Buenos Aires | Ciudad Autonoma Buenos Aires |
| Hospital Rawson | David, Daniel Omar | Argentina | Cordoba | Cordoba |
| Instituto del Buen Aire | Maillo, Martin | Argentina | Santa Fe | Santa Fe |
| Sanatorio del Oeste Ituzaingo | Remolif, Christian | Argentina | Buenos Aires | Ituzaingo |
| Hospital Interzonal General de Agudos Dr Jose Penna | Ditondo, Juan Carlos | Argentina | Buenos Aires | Bahia Blanca |
| Mater Hospital Brisbane | Griffin, Paul | Australia | Queensland | South Brisbane |
| Northside Health | Voloshyna, Olga | Australia | New South Wales | Coffs Harbour |
| AKH - Medizinische Universitaet Wien | Thalhammer, Florian | Austria | NA | Vienna |
| SMZ Süd - Kaiser Franz Josef Spital Wien | Zoufaly, Alexander | Austria | NA | Wien |
| Calozet, Yvan | Calozet, Yvan | Belgium | NA | Gribomont |
| BVBA Dr. Luc Capiau | Capiau, Luc | Belgium | NA | Wetteren |
| Research Link | Heijmans, Stéphane | Belgium | NA | Linkebeek |
| Mortelmans, Jaak | Mortelmans, Jaak | Belgium | NA | Oostham |
| De Meulemeester, Marc | de Meulemeester, Marc | Belgium | NA | Gozée |
| CHU Saint-Pierre | De Wit, Stephane | Belgium | NA | Bruxelles |
| Institut Jules Bordet | Aoun, Mickael | Belgium | NA | Bruxelles |
| Hopital Erasme | Hites, Maya | Belgium | NA | Bruxelles |
| Testumed VZW | Bouwen, Leen | Belgium | NA | Tessenderlo |
| CCBR Brasil Centro de Pesquisas e Análises Clínicas Ltda. | Geller Wolff, Priscila | Brazil | Rio do Janeiro | Rio do Janeiro |
| CECIP - Centro de Estudos Clínicos do Interior Paulista | Yukiko Urakawa Tokunaga, Paula | Brazil | Sao Paulo | Jaú |
| Fundacao José Luiz Egydio Setúbal | de Oliveira Junior, Francisco Ivanildo | Brazil | Sao Paulo | Sao Paulo |
| Santa Casa de Misericórdia de Belo Horizonte | de Faria Freire, Antonio Tarcísio | Brazil | Minas Gerais | Belo Horizonte |
| Pesquisare | De Oliveira, Carlos Alberto | Brazil | Sao Paulo | Santo André |
| Hospital Sao Vicente de Paulo | Stobbe, Júlio César | Brazil | Rio Grande do Sul | Passo Fundo |
| CMiP - Centro Mineiro de Pesquisa | de Souza, Rodrigo Daniel | Brazil | Minas Gerais | Juiz de Fora |
| CEMEC – Centro Multidisciplinar de Estudos Clínicos | Francisco Pez, Andréia Luísa | Brazil | Sao Paulo | Sao Bernardo do Campo |
| Irmandade da Santa Casa de Misericórdia de Sao Paulo | Naaman Berezin, Eitan | Brazil | Sao Paulo | Sao Paulo |
| Hospital Sao Lucas da PUCRS | Ramos, Fabiano | Brazil | Rio Grande do Sul | Porto Alegre |
| Hospital de Clínicas de Porto Alegre | Sprinz, Eduardo | Brazil | Rio Grande do Sul | Porto Alegre |
| Infection Control LTDA | Starling, Carlos | Brazil | Minas Gerais | Belo Horizonte |
| HRPC - ULBRA | Walker Zettler, Eduardo | Brazil | Rio Grande do Sul | Canoas |
| Diagnostic Consultative Center II - Sofia OOD | Loboshka-Becheva, Mariya | Bulgaria | NA | Sofia |
| SHATPPD-Ruse EOOD | Metev, Hristo | Bulgaria | NA | Ruse |
| Medical Center | Popov, Todor | Bulgaria | NA | Sofia |
| MC | Iliev, Ivo | Bulgaria | NA | Vidin |
| MHAT | Lund, Borislav | Bulgaria | NA | Sofia |
| Military Medical Academy - MHAT - Sofia | Tzvetkov, Ventzislav | Bulgaria | NA | Sofia |
| Medical Center | Genova, Sonya | Bulgaria | NA | Sofia |
| MDHAT 'Dr. Stefan Cherkezov', AD | Kolev, Konstantin | Bulgaria | NA | Veliko Tarnovo |
| Acibadem City Clinic DCC Tokuda EAD | Stoycheva, Galina | Bulgaria | NA | Sofia |
| Fifth MHAT - Sofia EAD | Alexandrov, Kalin | Bulgaria | NA | Sofia |
| Recherche Clinique Sigma Inc. | Chouinard, Guy | Canada | Quebec | Quebec |
| SKDS Research Inc. | Henein, Sam | Canada | Ontario | Newmarket |
| Commonwealth Medical Clinic | O'Keefe, Dennis | Canada | Newfoundland | Mount Pearl |
| Aggarwal and Associates Ltd | Aggarwal, Naresh | Canada | Ontario | Brampton |
| Weston Road Medical Clinic | Goldman, Howard | Canada | Ontario | Toronto |
| Dr. Anil K. Gupta Medicine Professional Corporation | Gupta, Anil | Canada | Ontario | Toronto |
| Bluewater Clinical Research Group Inc. | O'Mahony, Michael | Canada | Ontario | Sarnia |
| Central Alberta Research Clinic (CARe Clinic) | Odendaal, Morne | Canada | Alberta | Red Deer |
| Hospital de Ninos y Cunas | Quilodran Silva, Carlos Nelson | Chile | NA | Vina |
| Centro de Investigacion del Maule | Silva Orellana, Rafael | Chile | NA | Talca |
| Hospital El Pino | Palma Carvajal, Juan Carlos | Chile | NA | Santiago |
| Praktik Pb s.r.o. | Sedivy, Jakub | Czech Republic | NA | Pribram |
| Saniga s.r.o. | Vlasak, Zdenek | Czech Republic | NA | Sokolov |
| Nemocnice Kyjov p.o. | Blazek, Josef | Czech Republic | NA | Kyjov |
| SANARE s.r.o. | Matousová, Alexandra | Czech Republic | NA | Ceske Budejovice |
| SARKAMED s.r.o. | Koumarova, Sarka | Czech Republic | NA | Slany |
| ADMED s.r.o. | Pavlasek, Miroslav | Czech Republic | NA | Ceske Budejovice |
| Family Doctors Rauam & Gavronski | Rauam, Liivia | Estonia | NA | Tartu |
| Private GP Ilme Last | Last, Ilme | Estonia | NA | Paide |
| Vee Family Doctor`s Center OY | Alt, Ingrid | Estonia | NA | Paide |
| Pirita Family Doctors Centre | Arbeiter, Kaja | Estonia | NA | Tallinn |
| Merelahe Family Doctors Centre | Lanno, Riin | Estonia | NA | Tallinn |
| Oü Innomedica | Talli, Jaak | Estonia | NA | Tallinn |
| Centre Hospitalier Intercommunal de Créteil | Epaud, Ralph | France | Val de Marne | Creteil cedex |
| CHU Nantes - Hotel Dieu | Cattin, Guillaume | France | Loire Atlantique | Nantes Cedex 1 |
| Hopital Bichat - Claude Bernard | Yazdanpanah, Yazdan | France | Paris | Paris Cedex 18 |
| Centre Hospitalier Agen | Fort, Pierre-Arnaud | France | Lot et Garonne | Agen cedex 9 |
| CHU de Grenoble - Hopital Albert Michallon | Stahl, Jean-Paul | France | Isere | La Tronche |
| Hopital Bichat - Claude Bernard | Casalino, Enrique | France | Paris | Paris cedex 18 |
| Hopitaux Pediatriques de Nice CHU-Lenval | Haas, Herve | France | Pas de Calais | Nice |
| Hopital Cochin | Launay, Odile | France | Paris | Paris cedex 14 |
| Centre Hospitalier Départemental Les Oudairies | Frey, Jérome | France | Vendee | La Roche S/ Yon Cedex 9 |
| Jung, Thomas | Jung, Thomas | Germany | Baden Wuerttemberg | Deggingen |
| Gemeinschaftspraxis Dr. Klein/ Minnich | Klein, Christiane | Germany | Bayern | Kuenzing |
| Gemeinschaftspraxis Dr. Taeschner / Dr. Bonigut | Taeschner, Heidrun | Germany | Sachsen | Leipzig |
| Universitaetsklinikum Giessen und Marburg GmbH Standort Giessen | Herold, Susanne | Germany | Hessen | Giessen |
| MECS GmbH Cottbus | Kaessner, Frank | Germany | Brandenburg | Cottbus |
| Universitaetsklinikum Erlangen | Harrer, Thomas | Germany | Bayern | Erlangen |
| Tudogyogyintezet Torokbalint | Laki, Istvan | Hungary | NA | Torokbalint |
| Medifarma-98 Kft. | Zilahi, Zsolt | Hungary | NA | Nyiregyhaza |
| Universitaetsklinikum Koeln | Faetkenheuer, Gerd | Germany | Nordrhein Westfalen | Koeln |
| Futurenest Klinikai Kutato Kft. | Hajdu, Gabriella | Hungary | NA | Miskolc |
| Strazsahegy Medicina Bt. | Kajetan, Miklos | Hungary | NA | Budapest |
| BORBANYA PRAXIS Kft. | Vasas, Szilard | Hungary | NA | Nyiregyhaza |
| DRC Gyogyszervizsgalo Kozpont Kft. | Pauer, Jozsef | Hungary | NA | Balatonfured |
| DRC Zirc | Peterfai, Eva | Hungary | NA | Zirc |
| DRC Szentendre | Hasitz, Agnes | Hungary | NA | Szentendre |
| Obudai Egeszsegugyi Centrum Kft. | Danos, Peter | Hungary | NA | Budapest |
| DRC Zamardi | Literati-Nagy, Botond | Hungary | NA | Zamardi |
| Bugat Pal Korhaz | Sipos, Valeria | Hungary | NA | Gyongyos |
| Clinexpert Kft. | Urban, Veronika | Hungary | NA | Budapest |
| Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak | Vasas, Szilvia | Hungary | NA | Budapest |
| Pestszentimrei Gyermekrendelo | Batta, Ildiko | Hungary | NA | Budapest |
| Mohacsi Korhaz | Papp, Marta | Hungary | NA | Mohacs |
| M S Ramaiah Memorial Hospital | Kulkarni, Sanjay | India | Karnataka | Bangalore |
| Sir Ganga Ram Hospital | Gogia, Atul | India | Delhi | New Delhi |
| S. R. Kalla Memorial Gastro & General Hospital | Agarwal, Avinash | India | Rajasthan | Jaipur |
| Unique Hospital | Gami, Samir | India | Gujarat | Surat |
| BAPS Pramukhswami Hospital | Koradia, Parshottam | India | Gujarat | Surat |
| Siddhi Hospital | Mutha, Abhinandan | India | Maharashtra | Nashik |
| BLK Super Specialty Hospital | Nayar, Sandeep | India | Delhi | New Delhi |
| Midland Healthcare & Research Center | Singh, Bhanu | India | Uttar Pradesh | Lucknow |
| Kasturba Medical College | Varma, Muralidhar | India | Karnataka | Manipal |
| Rajiv Gandhi Institute of Medical Sciences | Naik, Sunil | India | Andhra Pradesh | Srikakulam |
| Lifepoint Multispecialty Hospital | Nikalje, Rajkumar | India | Maharashtra | Pune |
| Shree Giriraj Multispeciality Hospital | Thakker, Mayank | India | Gujarat | Rajkot |
| Suretech Hospital and Research Centre Limited | Jaiswal, Nirmal | India | Maharashtra | Nagpur |
| Sahyadri Specialty Hospital | Patwardhan, Kapil | India | Maharashtra | Pune |
| Barzilai MC | Maayan, Shlomo | Israel | NA | Ashkelon |
| Chaim Sheba Medical Center | Rahav, Galia | Israel | NA | Ramat Gan |
| Bnai Zion Medical Center | Schiff, Elad | Israel | NA | Haifa |
| Ziv Medical Center | Hussein, Osamah | Israel | NA | Safed |
| Galilee Medical Center | Nimer, Assy | Israel | NA | Nahariya |
| Kaplan Medical Center | Fink, Gershon | Israel | NA | Rechovot |
| Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia | Esposito, Susanna | Italy | Perugia | Perugia |
| Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo) | Migliorino, Guglielmo Marco | Italy | Milano | Monza |
| A.O.U. Policlinico di Modena | Mussini, Cristina | Italy | Modena | Modena |
| Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda) | Puoti, Massimo | Italy | Milano | Milano |
| Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma) | Biban, Paolo | Italy | Verona | Verona |
| Chungbuk National University Hospital | Jeong, Hye Won | Korea, Republic of | Chungcheongbuk-do | Cheongju-si |
| Hallym University Kangnam Sacred Heart Hospital | Lee, Jacob | Korea, Republic of | NA | Seoul |
| Hallym University Dongtan Sacred Heart Hospital | Woo, Heung Jeong | Korea, Republic of | Gyeonggi-do | Hwaseong-si |
| Yonsei University Wonju Severance Christian Hospital | Kim, Hyo-Youl | Korea, Republic of | Gyeonggi-do | Wonju-si |
| Korea University Guro Hospital | Kim, Woo-Joo | Korea, Republic of | NA | Seoul |
| Inha University Hospital | Lee, Jin Soo | Korea, Republic of | NA | Incheon |
| The Catholic University of Korea, Incheon St. Mary's Hospital | Ahn, Joong Hyun | Korea, Republic of | NA | Incheon |
| Korea University Anam Hospital | Sohn, Jang-Wook | Korea, Republic of | NA | Seoul |
| Korea University Ansan Hospital | Park, Dae-Won | Korea, Republic of | Gyeonggi-do | Ansan-si |
| The Catholic University of Korea, St. Vincent's Hospital | Wie, Seong-Heon | Korea, Republic of | Gyeonggi-do | Suwon-si |
| Asan Medical Center | Woo, Jun Hee | Korea, Republic of | NA | Seoul |
| Dong-A University Hospital | Jung, Dong Sik | Korea, Republic of | NA | Pusan |
| Konkuk University Medical Center | Yoo, Kwang Ha | Korea, Republic of | NA | Seoul |
| OLVI Medical Centre | Mitrofanova, Lilita | Latvia | NA | Daugavpils |
| Medical Practice BINI | Borsa, Ludmila | Latvia | NA | Ventspils |
| Clinic of GP A.Lasmanis | Lasmanis, Andris | Latvia | NA | Riga |
| S. Boreiko Doctor`s Practice | Boreiko, Silvija | Latvia | NA | Ogre |
| Children`s Clinical University Hospital | Zavadska, Dace | Latvia | NA | Riga |
| Meissana LLC | Cebere, Inese | Latvia | NA | Liepaja |
| Dr. R. Eglite`s Private practice | Eglite, Ruta | Latvia | NA | Kuldiga |
| Dr Liga Kozlovska Family Doctor Practice | Kozlovska, Liga | Latvia | NA | Balvi |
| Health Centre 4 | Adijane, Elita | Latvia | NA | Riga |
| Baiba Bake GP practice | Bake, Baiba | Latvia | NA | Jelgava |
| Inese Petrova General Practitioner Practice | Petrova, Inese | Latvia | NA | Tukums |
| Siauliai Republican Hospital, Public Institution | Kausas, Aidas | Lithuania | NA | Siauliai |
| Vilnius University Hospital Santaros Klinikos, Public Institution | Venceviciene, Lina | Lithuania | NA | Vilnius |
| Inmedica, JSC | Kucinskiene, Alina | Lithuania | NA | Kaunas |
| Inlita, JSC, Lazdynai KTC (clinical trial site) | Grigiene, Giedre | Lithuania | NA | Vilnius |
| Auki Sveikas | Kalasuniene, Rutele | Lithuania | NA | Kaunas |
| Inlita, JSC, Center of Santaros Clinical Trials | Radzisauskiene, Daiva | Lithuania | NA | Vilnius |
| Saules Seimos Medicinos Centras, JSC | Urboniene, Audrone | Lithuania | NA | Kaunas |
| Klinik Kesihatan Kuang | Chang, Li Cheng | Malaysia | Selangor | Kuang |
| Hospital Miri | Fam, Tem Lom | Malaysia | Sarawak | Miri |
| Hospital Taiping | Cheah, Wee Kooi | Malaysia | Perak | Taiping |
| Klinik Kesihatan Cheras Baru | Wong, Ping Foo | Malaysia | Kuala Lumpur | Cheras Baru |
| Hospital Cardiologica Aguascalientes | Marquez Diaz, Francisco | Mexico | Aguascalientes | Aguascalientes |
| Clinical Trials Mexico S.A. de C.V. | Escalante Otero, Miguel Angel | Mexico | Hidalgo | Pachuca de Soto |
| Centro Medico Jojutla | Cruz Valdez, Aurelio | Mexico | Morelos | Jojutla de Juárez |
| Hospital Infantil de Mexico Federico Gomez | Moreno Espinosa, Sarbelio | Mexico | Distrito Federal | Mexico |
| Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez | Rendon Perez, Luis Adrian | Mexico | Nuevo León | Monterrey |
| Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde | Rodriguez Noriega, Eduardo | Mexico | Jalisco | Guadalajara |
| Centro de Investigacion Medico Biologica y Terapia Avanzada (CIMBYTA) | Montano Gonzalez, Efrain | Mexico | Jalisco | Guadalajara |
| Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada S.C. | Urquidez Bazua, Edgar | Mexico | Sinaloa | Culiacan |
| Hospital Civil de Guadalajara Dr. Juan I. Menchaca | Rodriguez Gonzalez, Daniel | Mexico | Jalisco | Guadalajara |
| Huisartsenpraktijk Top | Top, Peter | Netherlands | NA | Zwijndrecht |
| Huisartsenpraktijk Mangal | Mangal, Radjesh | Netherlands | NA | Den Haag |
| Huisartsenpraktijk Zijtregtop | Zijtregtop, Ton | Netherlands | NA | Rotterdam |
| Wellington Hospital | Taylor, James | New Zealand | NA | Wellington |
| Lakeland Clinical Trials | Williams, Michael | New Zealand | NA | Rotorua |
| Culloden Research Ltd | Sheahan, Davitt | New Zealand | NA | Papamoa |
| Southern Clinical Trials - Remuera | Murray, Phillipa | New Zealand | NA | Auckland |
| Kuang Tien General Hospital | Chen, Chun-Chih | People's Republic of China | Taiwan | Taichung City |
| Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare | Liu, Yung-Ching | People's Republic of China | Taiwan | New Taipei City |
| Taipei Municipal Wanfang Hospital Managed by Taipei Medical University | Ou, Tsong-Yih | People's Republic of China | Taiwan | Taipei |
| Taipei Medical University Hospital | Su, Chien-Tien | People's Republic of China | Taiwan | Taipei |
| National Taiwan University Hospital | Huang, Li-Min | People's Republic of China | Taiwan | Taipei |
| Hospital Maria Auxiliadora | De los Rios, Jorge | Peru | NA | Lima |
| Clinica Internacional | LLerena Zegarra, Eneyda Giuvanela | Peru | NA | Lima |
| Cliniica Sanna San Borja | Felix Hinojosa, Efrain Ciro | Peru | NA | Lima |
| Clinica Peruano Americana S.A | Camacho, Luis | Peru | NA | Trujillo |
| ETG Lodz | Mordaka, Robert | Poland | NA | Lodz |
| Powiatowe Centrum Medyczne w Wolowie Sp. z o.o. | Kozina, Maciej | Poland | NA | Brzeg Dolny |
| Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska | Napora, Piotr | Poland | NA | Wroclaw |
| Centrum Medyczne w Lancucie Sp.z o.o. | Plesniak, Robert | Poland | NA | Lancut |
| Gabinet Lekarski Pediatryczno-Alergologiczny | Bukowczan, Marcin | Poland | NA | Sucha Beskidzka |
| Malopolskie Centrum Alergologii | Bederska, Malgorzata | Poland | NA | Krakow |
| LLC | Nilk, Rostislav | Russian Federation | NA | Saint-Petersburg |
| Federal State Education Institition of Higher Education Kazan (Privolzhsky) Fedral University | Fassakhov, Rustem | Russian Federation | NA | Kazan |
| LLC | Pak, Tatiana | Russian Federation | NA | St. Petersburg |
| State Autonomous Institution of Healthcare of Yaroslavl region | Khokhlov, Alexander | Russian Federation | NA | Yaroslavl |
| FSBI | Zubkova, Tatiana | Russian Federation | NA | Saint-Petersburg |
| Limited Liability company | Unger, Maria | Russian Federation | NA | Omsk |
| State Autonomous Healthcare Institution of Yaroslavl Region Clinical Hospital No. 3 | Noskov, Sergey | Russian Federation | NA | Yaroslavl |
| LLC Outpatient department of Private Security Guards and Detectives | Popov, Valeriy | Russian Federation | NA | Saint-Petersburg |
| Siberian State Medical University | Starovoytova, Elena | Russian Federation | NA | Tomsk |
| Nemocnica s poliklinikou S. Kukuru Michalovce, a.s. | Zamba, Stefan | Slovakia | NA | Michalovce |
| ALERSA, s.r.o. | Safcakova, Daniela | Slovakia | NA | Kosice |
| Plucna ambulancia Hrebenar, s.r.o. | Hrebenar, Slavomir | Slovakia | NA | Spisska Nova Ves |
| Nemocnica arm. generala L. Svobodu Svidnik, a.s., | Pytliak, Marek | Slovakia | NA | Svidnik |
| Dr A Jacovides Clinical Trials Inc. | Jacovides, Andrew | South Africa | Gauteng | Midrand |
| Abdullah, IA | Abdullah, Ismail | South Africa | KwaZulu-Natal | Durban |
| Botho ke Bontle Health Services | Mogashoa, Mokgadi | South Africa | Gauteng | Pretoria |
| Pillai, P | Pillai, Perumal | South Africa | KwaZulu-Natal | Durban |
| Queenswood Clinical Trial Centre | Fulat, Muhammed | South Africa | Gauteng | Pretoria |
| CRISMO Bertha Gxowa Research Centre | Mamba, Musawenkosi | South Africa | Gauteng | Johannesburg |
| Wits Clinical Research | Badat, Aysha | South Africa | Gauteng | Johannesburg |
| Emmed Research | Breedt, Johannes | South Africa | Gauteng | Pretoria |
| Limpopo Clinical Research Initiative | Fouche, Leon | South Africa | Limpopo | Thabazimbi |
| Janari, EL | Janari, Emlyn | South Africa | Western Cape | Cape Town |
| Newtown Clinical Research | Mitha, Essack | South Africa | Gauteng | Johannesburg |
| Precise Clinical Solutions (Pty) Ltd | Naidoo, Visvakuren | South Africa | KwaZulu-Natal | Durban |
| Aliwal Shoal Medical Centre | Padayachee, Trevenesan | South Africa | KwaZulu-Natal | Umkomaas |
| Into Research | Siebert, Heidi | South Africa | Gauteng | Pretoria |
| Medicross Lyttelton | Engelbrecht, Ingrid | South Africa | Gauteng | Pretoria |
| Randles Road Medical Centre | Govind, Uttam | South Africa | KwaZulu-Natal | Durban |
| Johese Clinical Research | Greyling, Mario | South Africa | Gauteng | Pretoria |
| Josha Research | Lombaard, Johannes | South Africa | Free State | Bloemfontein |
| Dr AA Mahomed Medical Centre | Mahomed, Akbar | South Africa | Mpumalanga | Moloto |
| Moriana Clinical Research | Ntsepe, Lebeko | South Africa | Free State | Brandfort |
| Global Clinical Research SA | Olivier, Pieter | South Africa | KwaZulu-Natal | Durban North |
| Uhuru Clinical Trial Centre | Patel, Pradipkumar | South Africa | Western Cape | Cape Town |
| Peermed Clinical Trial Centre | Pillay-Ramaya, Larisha | South Africa | Gauteng | Kempton Park |
| Sebastian, Peter | Sebastian, Peter | South Africa | KwaZulu-Natal | Durban |
| Drs Dindar and Partners | Dindar, Fareed | South Africa | Mpumalanga | Breyten |
| Clinteam Vaal Clinical Trial Centre | Essack, Yakub | South Africa | Gauteng | Van der Bijl |
| Smartmed Research Centre | Gani, Mashra | South Africa | Eastern Cape | Port Elizabeth |
| DJW Research | Jurgens, Jaco | South Africa | Gauteng | Krugersdorp |
| Reddy, J | Reddy, Jeevren | South Africa | KwaZulu-Natal | Durban |
| Endocare Research | Schmidt, Stephen | South Africa | Western Cape | Cape Town |
| Jongaie Research | de Jong, Douwe | South Africa | Gauteng | Pretoria |
| Cardiology Clinical Research | Kapp, Cornelia | South Africa | Gauteng | Alberton |
| Hospital Universitario Clinico San Carlos | Estrada Perez, Vicente | Spain | Madrid | Madrid |
| Hospital Universitario San Cecilio | Hernandez Quero, Jose | Spain | Granada | Granada |
| Hospital Universitario La Paz | Calvo, Cristina | Spain | Madrid | Madrid |
| Hospital Alvaro Cunqueiro | Crespo Casal, Manuel | Spain | Pontevedra | Vigo |
| Hospital Universitario 12 de Octubre | Lalueza Blanco, Antonio | Spain | Madrid | Madrid |
| Complejo Hospitalario Universitario de Santiago | Martinon Torres, Federico | Spain | La Coruna | Santiago de Compostela |
| Hospital Universitario de La Princesa | de los Santos, Ignacio | Spain | Madrid | Madrid |
| Hospital General Universitario de Elche | Masia Canuto, Marie del Mar | Spain | Alicante | Elche |
| Hospital Universitario Virgen de las Nieves | Pasquau Liano, Juan | Spain | Granada | Granada |
| Hospital Universitario 12 de Octubre | Rojo Conejo, Pablo | Spain | Madrid | Madrid |
| Hospital Universitario Madrid Montepríncipe | Barberan, Jose | Spain | Madrid | Boadilla del Monte |
| Akardo MedSite | Olsson, ake | Sweden | NA | Stockholm |
| Akademiska Sjukhuset | Pauksens, Karlis | Sweden | NA | Uppsala |
| Skanes Universitetssjukhus | Nilsson, Anna | Sweden | NA | Malmo |
| Norrlands Universitetssjukhus | Rasmuson, Johan | Sweden | NA | Umea |
| Bumrungrad International Hospital | Anekthananon, Thanomsak | Thailand | Bangkok | Wattana |
| Siriraj Hospital | Chayakulkeeree, Methee | Thailand | Bangkok | Bangkok |
| Bamrasnaradura Infectious Disease Institute | Manosuthi, Weerawat | Thailand | Nonthaburi | Muang |
| Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University | Pitisuttithum, Punnee | Thailand | Bangkok | Ratchathewi |
| Dicle University, Medical Faculty | Celen, Mustafa Kemal | Turkey | NA | Diyarbakir |
| Hacettepe University Medical Faculty | Kara, Ates | Turkey | NA | Ankara |
| Adnan Menderes Univ. Med. Fac. | Sakarya, Serhan | Turkey | NA | Aydin |
| Karadeniz Tecnical Uni. Med. Fac. | Koksal, Iftihar | Turkey | NA | Trabzon |
| Kocaeli Universitesi Tip Fakultesi | Cetin Akhan, Sila | Turkey | NA | Kocaeli |
| Uludag University Medical Faculty | Kazak, Esra | Turkey | NA | Bursa |
| Hacettepe University Medical Faculty | Unal, Serhat | Turkey | NA | Ankara |
| Poltava Regional Clinical Infectious Hospital Dept of Diagnostics HSEIU Ukrainian Medical Stomatolog | Dubyns'ka, Galyna | Ukraine | NA | Poltava |
| Med San Unit PJSC Kharkiv Tractor Plant Dept of Ther KMA PGE | Korzh, Oleksii | Ukraine | NA | Kharkiv |
| Oleksandrivska Clinical Hospital of Kyiv | Minova, Lyudmyla | Ukraine | NA | Kyiv |
| CCH #1 Vinnytsia M.I.Pyrogov NMU Ch of Infectious Diseases | Moroz, Larysa | Ukraine | NA | Vinnytsia |
| Odesa City Municipal Institution Polyclinic #2#N/A | Telyatnikova, Zinaida | Ukraine | NA | Odesa |
| Bodey Medical Centre | Tomkinson, Stephen | United Kingdom | Greater Manchester | Manchester |
| West Timperley Medical Centre | Stratford Smith, Philip | United Kingdom | Greater Manchester | Manchester |
| Northenden Group Practice | Kanumilli, Naresh | United Kingdom | Greater Manchester | Bolton |
| Barlow Medical Centre | Allcock, Damian | United Kingdom | Greater Manchester | Manchester |
| Swan Lane Medical Centre | Nixon, Paul | United Kingdom | Lancashire | Bolton |
| Center for Clinical Trials, LLC | Mangune, Edwin | United States | California | Paramount |
| ACRC Trials | Schultz, Rita | United States | Texas | Austin |
| J. Lewis Research Inc.- Foothill Family Clinic South | Coleman, Stephen | United States | Utah | Draper |
| Health Concepts | Beasley, Richard | United States | South Dakota | Rapid City |
| The Community Research of South Florida | Carpio, Jose | United States | Florida | Hialeah |
| J. Lewis Research Inc.- Foothill Family Clinic South | Christensen, Shane | United States | Utah | Salt Lake City |
| Preferred Primary Care Physicians, Inc. | Gates, Michael | United States | Pennsylvania | Pittsburg |
| Hickory Research Center. | Stern, Thomas | United States | North Carolina | Hickory |
| HIRG, LLC dba Health Innovation Research Group | Dao, Timothy | United States | Texas | Arlington |
| Clinical Trials Management, LLC | Dulitz, David | United States | Louisiana | Metairie |
| Vita Health and Medical center | Labissiere, Jean-Claude | United States | Florida | Tamarac |
| Buckeye Health and Research | Florea, Robert | United States | Ohio | Columbus |
| Centennial Medical Group, PC | Geller, Steven | United States | Maryland | Elkridge |
| Moonshine Research Center, Inc | Ramos, Faride | United States | Florida | Doral |
| Scottsboro Quick Care Clinic | Ismail, Younus | United States | Alabama | Scottsboro |
| J. Lewis Research, Inc. - Jordan River Family Medicine | Julien, Katie | United States | Utah | South Jordan |
| Best Quality Research Inc. | Ledo-Sanchez, Gustavo | United States | Florida | Hialeah |
| J. Lewis Research - FirstMed East | Plunkett, Stephanie | United States | Utah | Salt Lake City |
| MediSphere Medical Research Center, an AMR affiliate | Reyes, Hubert | United States | Indiana | Evansville |
| Burke Primary Care | Smith, Stephen | United States | North Carolina | Morganton |
| Village Health Partners | Ampajwala, Madhavi | United States | Texas | Plano |
| The Nebraska Medical Center | Berg, Isaac | United States | Nebraska | Grand Island |
| South Broward Research, LLC | Blaze, Kenneth | United States | Florida | Pembroke Pines |
| WR-Global Medical Research, LLC | Ebuh, Valentine | United States | Texas | DeSoto |
| Lucita M. Cruz, MD, Inc | Cruz, Lucita | United States | California | Norwalk |
| Frontier Clinical Research | Goisse, Marcy | United States | Pennsylvania | Smithfield |
| Ark Clinical Research | Kim, Kenneth | United States | California | Long Beach |
| Advanced Research Institute | Lowe, John | United States | Utah | Ogden |
| Research Center of Fresno, Inc.V | Mariano, Hipolito | United States | California | Fresno |
| SIMA Research Clinic | Ortiz Munoz, Luis | United States | Florida | Miami |
| Craig A. Spiegel, MD | Spiegel, Craig | United States | Missouri | Bridgeton |
| Cahaba Research Inc. | Vaughn, Michael | United States | Alabama | Birmingham |
| BI Research Center | Troyan, Barry | United States | Texas | Houston |
| Axcess Medical Research, LLC | Shamaskin, Susan | United States | Florida | Wellington |
| Progressive Medicine of the Triad, LLC | Tarleton, Gregory | United States | North Carolina | Winston-Salem |
| Coral Research Clinic corp | Abreu, Edel | United States | Florida | Miami |
| William Beaumont Hospital | Bastani, Aveh | United States | Michigan | Troy |
| South Florida Research Center Inc. | Benitez, Omar | United States | Florida | Miami |
| Invocare Clinical Research Center | Boone, Tasha | United States | South Carolina | West Columbia |
| William Beaumont Hospital | Clark, Carol | United States | Michigan | Royal Oak |
| Montana Medical Research | Cone, Clancy | United States | Montana | Missoula |
| West Houston Clinical Research Services | DeValle, Oscar | United States | Texas | Houston |
| Ericksen Research & Development, LLC | Dixon, Tyler | United States | Utah | Clinton |
| Complete Family Care | Doehring, Larry | United States | Colorado | Northglenn |
| Clinical Research of Gastonia | Jarratt, Mikell | United States | North Carolina | Gastonia |
| Dairy Ashford Family Practice | Jiang, Nan | United States | Texas | Pearland |
| Adam D. Karns, MD | Karns, Adam | United States | California | Los Angeles |
| San Diego Sports Medicine & Family Health Center | Ralph, Lee | United States | California | San Diego |
| New Horizon Research Center, Inc | Nunez, Lazaro | United States | Florida | Miami |
| Snake River Research, PLLC | Nathan, Richard | United States | Idaho | Idaho Falls |
| Innovative Clinical Research, Inc. | Osea, Edgardo | United States | California | Harbor City |
| Allied Clinical Research | Palatnik, Mikhail | United States | California | Gold River |
| Grace Research, LLC | Palmer, April | United States | Louisiana | Shreveport |
| Crystal Biomedical Research | Rico, Angel | United States | Florida | Miami Lakes |
| Care Partners Clinical Research, LLC | Barbel-Johnson, Kim | United States | Florida | Jacksonville |
| OnSite Clinical Solutions, LLC | Bauer, Steven | United States | North Carolina | Charlotte |
| Medical Associates Research Group, Inc. | Bennett, Michael | United States | California | San Diego |
| Wilmington Health | Cannon, Kevin | United States | North Carolina | Wilmington |
| DeGarmo Institute of Medical Research | DeGarmo, Ronald | United States | South Carolina | Greer |
| Clinical Neuroscience Solutions, Inc. | Dever, Michael | United States | Florida | Orlando |
| The Research Group of Lexington, LLC | Farris, Neil | United States | Kentucky | Lexington |
| Massachusetts General Hospital | Filbin, Michael | United States | Massachusetts | Boston |
| Arcturus Healthcare, PLC | Fraser, Neil | United States | Michigan | Troy |
| Benchmark Research Sacramento | Hachigian, Greg | United States | California | Sacramento |
| MedPharmi | Jeanfreau, Robert | United States | Louisiana | Metairie |
| PMG Research of Knoxville | Kirby, John | United States | Tennessee | Jefferson City |
| PMG Research of Bristol, LLC | Martin, Frederick | United States | Tennessee | Bristol |
| PMG Research of Charleston, LLC | Mills, Richard | United States | South Carolina | Mount Pleasant |
| Downtown LA Research Center, Inc | Nadkarni, Salil | United States | California | Los Angeles |
| Millennium Clinical Trials, LLC - Arlington | Natividad, Maria Bella | United States | Virginia | Arlington |
| Wayne State University School of Medicine | Paxton, James | United States | Michigan | Detroit |
| J. Lewis Research, Inc. Foothill Family Clinic | Peterson, James | United States | Utah | Salt Lake City |
| Destin Pulmonary Critical Care, PLLS. | Phillips, David | United States | Florida | Santa Rosa Beach |
| Mercury Street Medical Group | Pullman, John | United States | Montana | Butte |
| University of Texas Medical Branch at Galveston | Rupp, Richard | United States | Texas | Galveston |
| Southwest Clinical Trials | Shaikh, Zeeshan | United States | Texas | Houston |
| PMG Research of Cary, LLC | Shoffner, Sylvia | United States | North Carolina | Cary |
| Southeastern Research Center LLC | Sigal, Barry | United States | North Carolina | Winston-Salem |
| Chase Medical Research, LLC | Soufer, Joseph | United States | Connecticut | Hamden |
| Family Medicine Associates of Texas, P.A. | Stewart, Jeffrey | United States | Texas | Carrollton |
| Tri-County Research, Inc. | Stoller, Stuart | United States | Michigan | Sterling Heights |
| California Allergy & Asthma Medical Group Inc. | Tan, Ricardo | United States | California | Los Angeles |
| Nuren Medical & Research Center | Vaca, Carlos | United States | Florida | Miami |
| Wayne State University School of Medicine | Wilburn, John | United States | Michigan | Detroit |
| San Gabriel Clinical Research, LLC | Willis, John | United States | Texas | Georgetown |
| AAPRI Clinical Research Institute | Zwetchkenbaum, John | United States | Rhode Island | Warwick |
| Combined Research Orlando | Ausaf, Niaz | United States | Florida | Orlando |
| The Johns Hopkins Hospital | Rothman, Richard | United States | Maryland | Baltimore |
| Saltzer Medical Group | Aguilar, Richard | United States | Idaho | Nampa |
| Barrett Clinic P.C. | Ahlers, Kevin | United States | Nebraska | La Vista |
| A+ Research Inc. | Ebran-Gonzalez, Raul | United States | Florida | Miami |
| Preferred Primary Care Physicians | Hartley, Paul | United States | Pennsylvania | Uniontown |
| Miller Children's at Long Beach Medical Center | Deveikis, Audra | United States | California | Long Beach |
| Monroe Biomedical Research | Igbinadolor, Awau | United States | North Carolina | Monroe |
| PCP for Life | Karimjee, Najmuddin | United States | Texas | Houston |
| Stanford University Hospital | Pearl, Ronald | United States | California | Stanford |
| DM Clinical Research | Reyes, Ramon | United States | Texas | San Antonio |
| JM Research.PLLC | Rodriguez, Julio | United States | Texas | Houston |
| Clinical Research of Lancaster | Shealy, Keith | United States | South Carolina | Lancaster |
| St. Michael's Medical Center | Slim, Jihad | United States | New Jersey | Newark |
| Om Research, LLC | Allen, Richard | United States | California | Lancaster |
| University of Maryland Medical Center | Wilkerson, Richard Gentry | United States | Maryland | Baltimore |
| Granger Medical Clinic - Riverton | Devenport, Stephen | United States | Utah | Riverton |
| Lynn Institute of the Rockies | Hollister, Ripley | United States | Colorado | Colorado Springs |
| Emerson Clinical Research Institute, LLC | Geddes, Caroline | United States | District of Columbia | Washington |
| HP Clinical Research. | Hansen, Val | United States | Utah | Bountiful |
| Ann & Robert H. Lurie Children's Hospital of Chicago | Muller, William | United States | Illinois | Chicago |
| Next Phase Research Alliance | Aguiar, Oricel | United States | Florida | Miami |
| SC Clinical Research, Inc. | Dao, Michael | United States | California | Garden Grove |
| PMG Research of Knoxville | Wakefield, Paul | United States | Tennessee | Knoxville |
| Detweiler Family Medicine & Associates | Kessler, Evan | United States | Pennsylvania | Lansdale |
| Alabama Clinical Therapeutics, LLC | Flippo, Gregory | United States | Alabama | Birmingham |
| Omega Research Consultants | Ayesu, Kwabena | United States | Florida | Debary |
| PMG Research of Rocky Mount, LLC | Browder, Lesley | United States | North Carolina | Rocky Mount |
| Spectrum Medical Research | Cutchin, Richard | United States | South Carolina | Gaffney |
| Homestead Associates in Research Inc | Seco, Gilberto | United States | Florida | Miami |
| ASCLEPES Research Centers, P.C. | Gupta, Neeraj | United States | California | Panorama City |
| Paradigm Clinical Research Centers, Inc. | Elzi, Stanton | United States | Colorado | Wheat Ridge |
| University of Texas Southwestern Medical Center | Jain, Mamta | United States | Texas | Dallas |
| Northwest Med Care,P.A. | Naygandhi, Yamini | United States | Texas | Cypress |
| Universal Clinical Research | Bermudez, Lidia | United States | Florida | Hialeah |
| ClinPoint Trials | Ledbetter, Thomas | United States | Texas | Waxahachie |
| Vista Health Research, LLC | Blanco, Antonio | United States | Florida | Miami |
| Renovatio Clinical | Siddiqi, Ather | United States | Texas | The Woodlands |
| Carolina Institute for Clinical Research | Ferro, Richard | United States | North Carolina | Fayetteville |
| Fusion Clinical Research of Spartanburg | Koser, Andras | United States | South Carolina | Spartanburg |
| Investigators Research Group, LLC | Maynard, Kenneth | United States | Indiana | Brownsburg |
| Tekton Research | Adetona, Olutola | United States | Texas | San Antonio |
| Premier Medical | Khanna, Dinesh | United States | Florida | The Villages |
| Asclepes Research Centers | Benson, Dalton | United States | Florida | Weeki Wachee |
| Albert Einstein Healthcare Network | Raspberry, Dara | United States | Pennsylvania | Philadelphia |
| SMS Clinical Research LLC. | Saiger, Salma | United States | Texas | Mesquite |
| Invocare Clinical Research Center | White II, Hubert | United States | South Carolina | West Columbia |
| Pines Care Research Center, Inc. | Moya, Jaynier | United States | Florida | Pembroke Pines |
| Encore Medical Research, LLC | Rondon, Juan | United States | Florida | Hollywood |
| Floridian Clinical Research | Sanchez, William | United States | Florida | Hialeah |
| Dayton Clinical Research | Schear, Martin | United States | Ohio | Dayton |
| West Coast Research | Tan, Alfred | United States | California | San Ramon |
| Hutchinson Clinic | Ruhlmann, James | United States | Kansas | Hutchinson |
| University of Alabama at Birmingham - (UAB) | Poole, Claudette | United States | Alabama | Birmingham |
| Cozy Research | Yousef, Jonathan | United States | Florida | Zephyrhills |
| University of Oklahoma Health Sciences Center | Metcalf, Jordan | United States | Oklahoma | Oklahoma City |
| Bach Mai Hospital | Do, Cuong | Vietnam | NA | Hanoi |
| National Hospital for Tropical Diseases | Nguyen, Kinh | Vietnam | NA | Hanoi |
| Nguyen Tri Phuong Hospital | Cao, Nhan | Vietnam | NA | Ho Chi Minh |
| Hospital of Lithuanian University of Health Sciences Kaunas Clinics | Valius, Leonas | Lithuania | NA | Kaunas |
伦理委员会信息
| 名称 | 审查结论 | 审查日期 |
|---|---|---|
| 中日友好医院临床研究伦理委员会 | 同意 | 2019-06-19 |
| 中日友好医院临床研究伦理委员会 | 同意 | 2019-08-02 |
试验状态信息
试验状态
主动终止
目标入组人数
国内: 108 ；
国际: 720 ；
已入组例数
国内: 0 ；
国际: 553 ；
实际入组总例数
国内: 0 ；
国际: 553 ；
第一例受试者签署知情同意书日期
国内：登记人暂未填写该信息；
国际：2018-01-24；
第一例受试者入组日期
国内：登记人暂未填写该信息；
国际：2018-01-24；
试验终止日期
国内：2020-08-28；
国际：2020-08-28；
临床试验结果摘要
| 版本号 | 版本日期 |
|---|
